Device recall

Z-0934-2011: Lubricating Jelly, Sterile, Non-staining, Made in the USA, packaged into the…

FDA device recall · Class II · H & P Industries, Inc. dba Triad Group

Key facts

Recall number (Z-number) Z-0934-2011
Recall event 57612
Product Lubricating Jelly, Sterile, Non-staining, Made in the USA, packaged into the following size containers 5 gram tube, 2 ounce and 4 ounce tubes, 4 ounce bottle, 3 and 5 gram packets Intended use: A patient lubricant is a device intended for medical purposes that is used to lubricate a body orifice to…
Product code KMJ
Recalling firm H & P Industries, Inc. dba Triad Group
Recall class Class II
Status Terminated
Termination date Jun 11, 2012
510(k) numbers K871169
FEI number 2128643

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recalls (products)